KCT0008856招募中Unknown
Effects of a ATNC MDD-V1 (TMS with cognitive training), for the Treatment of Mild Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study
AT&C0 个研究点目标入组 158 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 60(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1.Patients who started drug treatment with an acetylcholinesterase inhibitor at least 2 months before participating in the clinical trial and can participate in the clinical trial without changing the dose during the trial period.
- •2.Male or female age 60-85 years.
- •3.Patients diagnosed with mild stage of Alzheimer's Disease, according to the NIA-AA (2011) diagnosis.
- •4.MMSE score 21 to 26.
- •5.CDR 1 or GDS 3.
- •6.Patients with a positive amyloid PET-CT.
- •7.Patients who are judged physically capable of clinical trials based on medical records and examinations.
- •8.Patient whose legal representative agrees to participate in a clinical trial and who can visit for the next observation with a guardian.
- •9.Patients who agreed to participate in all 24-week clinical trials.
- •10.Patients with normal ability to see and hear letters.
- •11.Patients who speak Korean as their mother tongue.
排除标准
- •1.Patients with a central nervous system disease that can affect cognitive function and is likely to be another cause of cognitive decline, or a type of dementia other than Alzheimer's, is suspected.
- •2.Patients who have been unconscious due to brain surgery or concussion, or who have signs or symptoms of cranial pressure elevation on neurologic examination.
- •3.History of Epileptic Seizures or Epilepsy.
- •4.Patients with a history of drug abuse, including alcohol, in the past 5 years from the time of screening.
- •5.Patients with schizophrenia, schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress, severe anxiety, mental retardation, DSM-V disorder.
- •6.Patients with abnormal vitamin B12, folic acid deficiency, or thyroid stimulating hormone (TSH) test results that were considered by the investigator to affect or are caused by the severity of dementia.
- •7.Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants.
- •8.Cardiac pacemakers.
- •9.Implanted medication pumps.
- •10.Intracardiac lines.
- •11.Patients who are currently taking medications that lower the convulsive seizure threshold.
- •12.Significant heart disease.
- •13.Significant renal disease, Significant hepatic disease.
- •14.Contraindication for performing MRI scanning.
- •15.Contraindication for performing amyloid PET-CT scanning.
- •16.Patients who do not consent to TMS treatment and participation in this clinical trial.
- •17.Patients who participated in other clinical trials 3 months before participating in this clinical trial.
- •18.Patients with a history of TMS treatment within the last 2 years before participating in this clinical trial.
- •19.Patients judged by the investigator to be unsuitable for participation in clinical trials for other reasons.
- •20.Patients with a history of malignant tumors within the last 5 years.
- •-Participation is possible if more than 5 years have elapsed without recurrence after the decision to be cured (The point of complete removal of the tumor through surgery or the end of chemotherapy, etc.).
- •21.Patients who need to take medications suggested in concomitantly contraindicated drugs.
研究者
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